Quality , Science, Pharmaceutical & Food
Quality & Regulatory Specialist
- Full Time
PE Global is currently recruiting for a Quality & Regulatory Specialist for a leading mu client based in Little Island Cork.
This is a permanent position.
- Ensures compliance with cGMP’s & Environmental, Health & Safety regulations.
- Ensure compliance & execute all activities to the BluePoint Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
- Executes the finished product non-conformance process.
- Supports document reviews to ensure timely release of finished product.
- Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
- Manages & executes all routine regulatory updates & submissions of finished product labelling.
- Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
- Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
- Ensures the company and product is registered in the appropriate markets & with agencies as required.
- Reviews and approves product labeling, patient package inserts and other product labeling.
- Executes the document control system & record retention.
- Develops, implements and maintains Standard Operating Procedures.
- Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
- Maintain familiarity with current regulatory trends.
- Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
- Performs related duties as assigned.
- Minimum requirement of a BSc in a scientific discipline; minimum of five (5) years in a cGMP facility in a Quality Assurance role.
- Essential to have good communication and attention to detail.
- Experience in the Pharmaceutical industry is essential.
- Experience in Medical Device regulations is desirable but not essential.
- Excellent oral and written communication skills
- Ability to effectively manage and participate in cross-functional problem-solving teams
- Ability to read and understand the English language for the purpose of following instructions
- Ability to develop and maintain cooperative working relationships with others.
- Ability to use good judgment in order to carry out detailed instructions
- Ability to work independently
- Excellent teamwork and interpersonal skills
- Ability to handle a variety of tasks simultaneously
- Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
- Ability to apply critical thinking on review of all quality related procedures and documents
- Excellent attention to detail
- Artwork review/Regulatory experience desirable
- Supplier Quality
- Quality Systems
- Computer literate; Excel, Word, Document Management System, etc..
- Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up-to-date CV to Niamh.email@example.com.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***